Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

Hello. Welcome to Day 2 of the UBS Global Healthcare Conference. My name is Navin Jacob. I'm a senior analyst covering large cap pharmaceuticals and some mid-cap biotech. Our next presentation of fireside chat is with Bristol-Myers Squibb. It's my pleasure to have with me Chris Boerner, Chief Commercial Officer; as well as Samit Hirawat, Chief Medical Officer. Thank you, both Chris and Samit, for joining us today.

It's our pleasure.

Perfect. Well, let's -- we can't escape COVID, obviously. So maybe we'll just start off with a few questions there. Chris, given that Bristol is in the launch phase with a number of assets such as ZEPOSIA. And please correct me if my pronunciation, I suppose, is incorrect, as well as some cell therapies later in the year, what are the commercial -- the activities that the commercial and sales teams are conducting in order to navigate this environment?

Sure. Thanks for the question. So as I think we had discussed on our quarterly call, we made the decision back in early March to effectively move to remote operations, both from a commercial and medical standpoint. And what that decision was based on was, obviously, the health and safety of our employees but also, frankly, the needs of customers because we were, at that time, sort of in the throes of the distraction and imposing of institutional constraints on the customer side, and that also made personal interactions more difficult. So what that means effectively is that all of our sales and field medical teams have moved to engagement only on a remote basis. We continue to engage with payers, but it's remote. We've staffed all of our relevant medical affairs and patient access support centers, but again, that's all from a remote standpoint. The good news, from our perspective, is that a lot of the core digital and remote technology capabilities required here are investments that we've made over many, many years. And so our experience with these technologies is not just over the last few months, but we've been able to leverage these technologies for some time. What that means practically is virtually all of our promotional and medical content is available digitally. We've rolled out technology platforms globally that allow for remote meetings and the exchange of content. And so we've been able, through this COVID period, to really leverage those across the majority of our products and, frankly, most of our markets. And that's really allowed us to continue the core of our operations, which is to ensure the safe and effective use of our products. Now I think underpinning your question is, are there limits? And there certainly are. There's scale. You have to -- historically, you would think about remote engagement as a channel. Now it's the channel. So we've had to scale up. Second challenge is the ability of our customers to engage remotely, and that's not uniform. So we've had to meet our customers where they are, and then probably, most importantly, is the level of distraction for customers that exist with COVID. So some types of interactions are more challenging than others, presenting fundamentally new information or complex information can be challenging in a remote setting. So as a result, we've kind of defaulted to being very flexible in our approach. You mentioned ZEPOSIA, and you pronounced it correctly. We made the decision, primarily, because it's a new agent with a fundamentally new profile to not initially launch that product. We will be launching on June 1, but we delayed that launch in contrast with Reblozyl and MDS and most recently with first-line lung, we did move to remote launch of those indications. And so we're going to continue to be flexible, but in general, we've been able to adapt pretty well.

That's great. And so with regards to virtual detailing, I mean some of some other questions we've been asking folks, is there a longer-term impact with regards to the ability to detail talks virtually? Is this something that is a trend that is going to stay beyond COVID-19 even when things get back to "normal"? And as a result of their ability to, for savings, that perhaps that we're not thinking through over the long term?

Well, I think that our going-in assumption, and it has really underpinned the investments I alluded to previously, was that, over time, increasingly, you would see remote engagement with customers of all types, become increasingly important. I think COVID is accelerating that for a couple of reasons. First, it's requiring people to get up the learning curve really quickly, both on the industry side as well as on the customer side. Second, those organizations that have not invested both on the industry and customer side as we have, have been forced to make those investments and do so very quickly. And I think you're going to continue to see those trends potentially accelerate even in the post-COVID world. So our assumption is that remote detailing is likely going to accelerate a trend that was already in existence. With respect to what that means in terms of overall cost infrastructure, I think it really depends upon where organizations were in the process of building the core capabilities and technology to engage effectively on the -- from a remote standpoint. And certainly, we feel pretty good about where we were from that perspective. And then, obviously, the -- what you decide to do with respect to field employees. Now it is our belief that we will continue to see field employees being required both on the commercial and medical side. As I mentioned, there are some conversations that are simply better done in person. But undoubtedly, COVID has forced a bit of a reset with respect to the importance of remote engagement. It's something certainly from a Bristol-Myers Squibb standpoint, we're going to continue to make important investments in.

Fantastic. And then, Samit, for ASCO, we've seen the 9LA data in the abstract. What patient groups do you think benefit most from a triplet regimen that was studied in 9LA relative to KEYTRUDA plus chemo? And then when we see the data at ASCO itself, are we going to see an update? I believe we're going to see an update, either ASCO or AACR with regards to a new cut -- a more -- a later cut of data. Any expectations we should have there?

Sure. Thank you for the question, Navin. So from just non-small cell lung cancer perspective, I think we should start off, and you know this very well, that there is still a very high unmet medical need despite what the standard of care has been set in terms of the immuno-oncology products along with chemotherapy, and we have to continue to evolve. And so when we look at the data, we look at it holistically, looking both at CheckMate -227, which brings the first time dual IL therapy. And then, of course, CheckMate 9LA, which brings a limited amount of chemotherapy with 2 cycles with Opdivo and low-dose Yervoy. So from that perspective, if you think about what physicians might be looking for, if you think about what the patients really need is prolongation and survival. So at ASCO -227 would be the first of the first-line study that we'll be presenting. We'll be presenting the 3-year follow-up data for overall survival. I do not like to compare across studies because, again, each study has its own nuance. Each study has subtleties in terms of the patient population, et cetera. But the truth of the matter is that we will be able to present a 3-year data looking at overall survival with 1/3 of the patients still surviving at this time, and then, of course, there is the tail of the curve, which is quite mature, and we can see longer duration impact now. For 9LA in a similar way, you recall, we had finished enrollment at the beginning of last year. So when we had the interim analysis where the trial read out positive, the overall timing and the follow-up was at least short. But still, we have the number of events to do the analysis. The trial turned out to be really positive, and we were going to have that data. And at ASCO, we'll be able to present the first look in terms of the second cut of the data that you will see at ASCO. We will continue to follow these patients, and it's interesting how the curve has evolved and we are beginning to see, maybe, the evolution of that tail of the curve that we talked about, which is very important in the IO checkpoint inhibitor trials. And so we will continue to follow these patients. We will have evolution of this data. I can't tell you today whether it will be at next year's AACR or next year at ASCO, but we certainly have that in mind as we continue to look forward. How do you define which patients should get what? I think there are several factors that will play into it. Patients who may not want chemotherapy or are not candidates for chemotherapy or should be given a shortened duration of chemotherapy, that's how we have to look between -227 and the 9LA. There certainly is going to be a lot of competition, and certainly, Chris will talk more about it. But from a physician perspective, from a clinical perspective, from a clinical trial perspective, the way we looked at it is, number one, 9LA brings to bear a new treatment regimen that is now an option for providing the long-term overall survival benefit in a condition where there is still a very high unmet medical need. Chris, do you want to add something?

The only thing I would add is that I think the consistent feedback that we have gotten from the many physicians that we have shared the -227 data as well as the discussions we've had in a blinded way on 9LA before the ASCO presentation, the thing that has continued to stick in the minds of physicians who have seen the data, is that the depth and durability of responses that you get with dual IO therapy is something that continues to be an area of unmet need in first-line lung cancer, given the fact that the majority of patients treated with standard of care IO plus TKI are going to relapse within 12 to 18 months.

Sorry, I was on mute for a second there. There were some -- or some new data from competitors and new mechanisms, specifically TIGIT, Roche's tiragolumab in non-small cell. It looks like it is adding activity on top of TECENTRIQ. Maybe just a broad question here, purposely. So what's your take on that data set? And then separately, I believe you have a TIGIT as well in development that is in Phase I. When could we see data from this asset?

Samit can answer.

Sure. I think -- yes, I'll start off. And certainly, Chris, feel free to add after that. TIGIT is an interesting mechanism as we think about the target itself. It's both inhibitory and stimulatory domain. So one has to think carefully in terms of how to go about it. We are seeing the first presentation or the evolution of this data through the abstract and certainly look at the presentation as well. All-comer population enrolled. We've seen the data in the abstract, relatively short follow-up thus far, but we start to see the emergence of the data in the high PD-1 expressers versus the low. We are beginning to see in a small population of about 50, 60 patients in those more than 50% expressers where we start to see the differentiation between single agent PD-L 1 inhibitor versus the combination, and that's interesting. So -- but I think it's too early to tell. I think jury's still out in terms of how that data will evolve and what the impact will be as we see in larger trials in terms of whether these data will be replicated or not. So that's the gist of my understanding at this time from that data perspective. We do have a TIGIT inhibitor in development for ourselves. It is in Phase I. It's in early Phase I, so there is no data to share yet. And there is -- I can't tell you today whether we'll be again presenting it at which conference at this time. But as it evolves, we'll certainly share as the time comes. Chris, if you want to add something?

No. I think you've covered it.

And one of the mechanisms or combos that I've been interested in at Bristol is the LAG-3 in combination with PD-1. Wondering when we could see more there what's your latest with regards to timing of the combo of LAG-3 plus Opdivo? And do you feel that -- are you developing this really for the PD-1 refractory setting? Or do you think it could move up -- higher up in the lines of therapy?

Sure. Certainly, we are equally excited, and we're looking forward to the first readout in the ongoing Phase III study, which is in the first-line setting in melanoma, nivo plus LAG-3 versus nivo, so active agent comparison here. We're looking forward to readout of this trial, either towards the end of this year or early next year. It's an enrollment at this time. We are certainly developing our overall plan in terms of life cycle management within melanoma and other tumor types as we continue to understand this target and the mechanism and the evolution of the bio marker data as well. So that's the first readout, as I said, in melanoma and in the IO-naive setting. So that's already moved earlier in line. Now we have to see which other tumor types we can go into.

Another mechanism that's more novel that is being presented at ASCO is Merck's 6482 HIF alpha. Wondering how you're thinking about that mechanism. Is that something that you're interested in? I don't recall exactly if you are -- have something in the pipeline in this mechanism. Any clarity would be helpful.

Yes. I think at the current time, as far as I can look into our pipeline, we have more than 50 assets in Phase I/II development at this time. We don't have an alpha-targeting agent, as far as I know, in our pipeline. But then we are looking at it more holistically from the pipeline perspective in oncology way beyond just the vascular targeting per se. Now we'll see what the evolution of the data shows. I have not been able to get to that abstract yet, so I can't talk about specifically what the Merck data is showing at this time. Now others have targeted this and HIF-1 -- I believe you're talking about HIF-1 targeting, and that's been in development for a while in other places and other companies. And I think, let's see, I have not seen the data. So I cannot comment on that.

That's fine. Any other data sets that we should be most focused on at ASCO and AACR? What are you most -- besides what we've talked about in 9LA and -227?

Yes. Absolutely. I can start off over there. Certainly, look, we are in a new place in terms of having the ASCO as a virtual meeting, and it would have been absolutely amazing to be there in person, looking at more than 270 abstracts that we will be sharing at ASCO with more than 130-odd new disclosures. The key ones, so you've already heard about 9LA. You've highlighted -227 as well. In addition to all that, there is a huge amount of data being presented in multiple myeloma. But we have taken a holistic approach in terms of approaching multiple myeloma, looking at the cell therapies through ide-cel, Orva-cell, looking at BCMA targeting from a T-cell engager perspective. We also have a very early molecule looking at the ADC way of targeting BCMA. And then there are the back -- or the next-generation of molecules that are coming through the CEL MoDs. So at ASCO, you will see the data for ide-cel being presented for the first time from the KarMMa study. Looking at the outcomes of these -- outcomes in the patients who have very refractory or relapsed multiple myeloma as a disease. I have received lenalidomide, obviously, received pomalidomide as well as many a patients have received transplants as well as daratumumab, et cetera. And then we start to see the emergence of the efficacy profile of more than 70% of patients having a response across the doses, more than 1/3 of patients having a complete response and the durability of that response, which is quite remarkable. Overall, from the hematology perspective that we also will be seeing the data for, looking at Orva-cell, which is another cell therapy, again, evolution of that cell therapy platform that we have, very high response rates as well as CR rates. Next in line that we are looking at now is going to be the CEL MoDs, where we will see the evolution of data on deep understanding of how do you target the IMiD pathways and how that has evolved into the protein homeostasis platform and looking at degradation through [ Ikaros ] and ILOs and the impact in that heavily pretreated population in terms of responses in the late-line therapy where there is no standard of care. So these are hematology data, and then, of course, beyond that, we are going to see more evolution of data of outpatient treatment with JCAR017 through the TRANSCEND studies and how we evolve and as we look towards, hopefully, approval of liso-cel towards the end of this year, and we continue to go forward. Beyond that, biomarker data as well as specific population data and various hematological diseases as well as through CC-486. In the oncology side beyond the 9LA, -227, more data to be presented from the fraction trial and biomarker evolution, of many of these IO therapies that we continue to evolve through. These are going to play a major role as we continue to share the data through the community and how these drugs are used for diseases as we look forward. Chris, if you want to add something?

No. I think you've covered it.

That's very helpful. So Chris, maybe as we -- post 9LA, -227 and 9ER for renal cell carcinoma, what's your outlook post these data sets for Opdivo growth in 2021? Can you confirm that Opdivo will grow in '21 at both in the U.S. and globally as well?

Yes. So I think our position on Opdivo growth remains unchanged. We still see Opdivo as a growth brand. The fundamentals for Opdivo the first quarter of this year are very much in line with expectations. As we've said, 2020 is going to be a year of transition with really different dynamics globally. Ex U.S., we continue to see very good growth this year as the base business continues to remain strong. We see good growth in adjuvant melanoma, first-line renal and most of our larger ex U.S. markets. In the U.S., this is still under some pressure due to mainly declining eligibility in second-line lung as well as head and neck and small cell as a result of some competitive advancement in first-line in those 2 tumors. That said, the upcoming -- well, the launch that we have now with -227, the upcoming launch that we have next year with 9ER provide a very good foundation for growth in 2021. So yes, we continue to see Opdivo as growing in 2021. And what we've said consistently is that the shape of the growth in 2021 and beyond will be impacted by additional data readouts. Certainly, what we've seen from -227, the launch of 9LA later this year, the 9ER data, which we're very excited about, both from an efficacy and safety standpoint, those provide a very good foundation. And then we have additional metastatic studies, esophageal, gastric as well as adjuvant studies that will begin to read out, that will fundamentally shape the -- affect the shape of the growth trajectory 2021 and beyond. But our view on Opdivo remains unchanged, and we're excited about the opportunities to continue to grow this brand in the long term.

And then for the adjuvant setting, Samit, you have multiple readouts over the next 12 to 24 and 36 months. Could you remind us sort of the layout of how these trials will read out? I believe the first one that we may have an interim look on was CheckMate 8.6 and along with PCR analysis. But just help us out with sort of the layout, and then I'll dig into a couple of those topics, specifically.

Sure. Absolutely. And certainly, thank you for highlighting CheckMate 816. I'll come to that. But I think overall, one can imagine that as we continue to make progress in the immuno-oncology field, as we look at the progression of checkpoint inhibitors moving from the late-line therapy, we are now in multitude of diseases looking at the first-line treatment. So the natural progression was going to be looking at adjuvant treatments. Exciting data has emerged and evolved over time, looking at, for example, single agent nivolumab in the new adjuvant setting, having a 45% major responses in patients with non-small cell lung cancer. So certainly, multitude of studies that are ongoing, looking at evolution from the data perspective will be CheckMate -915 for multiple myeloma. I'm looking forward to that data readout later this year. In the muscle invasive bladder cancer, CheckMate -274, that's another adjuvant trial that's ongoing. I think coming to 816, yes, pathological complete response is an endpoint. Now one has to remember that there is no precedence per se for approval in non-small cell lung cancer, utilizing pathological complete response rate. So it will require a dialogue with the health authorities and agencies. So we will continue on that path and that if the data is supported -- if the agencies and the health authorities are supportive of that, then we will get to that place, but I want to be cautionary over there that there is no precedent. So we have to be taking that in a different way in terms of where we are leading to with the health authorities and the interactions that we will need to have. And beyond that, of course, then comes the gastric and esophageal trials, and then, of course, as you said, in non-small cell lung cancer, we've actually taken a more holistic approach now that we have the first-line lung approvals coming through -227 already approved. And then we're looking to the action date for 9LA. We do have the periadjuvant, neoadjuvant and adjuvant components as well as the unresectable indication looking at the comparison versus durvalumab as well.

And then, Chris, when we think about the adjuvant market, how should we think about the incremental sales? Could you give some relative comparison to the size of adjuvant non-small cell relative to first-line mets? And how -- what could treatment rates get to in the adjuvant setting? And where are they right now in some of these key adjuvant markets that you're going after, [indiscernible] and non-small cell? And well, melanoma, you're already there, but any kind of color would be helpful.

Sure. I think Samit has highlighted in his discussion, part of why we're excited about adjuvant. It's obviously a space where we think IO should work if you've got an intact immune system. You haven't beaten it up with chemotherapy. The data we've seen thus far are encouraging. You've highlighted our experience in adjuvant melanoma with Opdivo and now with monotherapy Yervoy, and then we'll see how the data that was referenced with respect to the -915 study on the combination. And we've also seen early data on Opdivo in neoadjuvant lung with path response rates. But above and beyond sort of the early data and the biologic rationale for the use of IO, these are potentially very large markets. And I think you highlight why we think there's a potential large opportunity to help patients here. Across these various tumors, the size of the population that's being treated today is -- it really varies. It varies from -- on the order in the U.S. patients in renal cell who were treated in the adjuvant setting to 10,000 to 15,000 patients in the U.S. treated in adjuvant lung cancer. But remember, these are relatively small compared to the metastatic setting in large part because the treatment rates are relatively low. So in renal, which I mentioned, the treatment rate is on the order of 15%. In lung cancer, it's on the order of 35% to 40%. And so much like what we saw when we introduced IO into the adjuvant setting, there's an opportunity to not only treat patients who are being treated today. But because the standard of care in most of these tumors is so poor in the adjuvant setting, by virtue of introducing agents that provide efficacy with a relatively benign safety profile, you have the opportunity to potentially expand the pool of patients being treated as we did in adjuvant melanoma. So we took treatment rates from the order of 15% to 20% to now upwards of 80%. And so I think that, that dynamic, data-dependent, obviously, could potentially play out as we see the data that Samit alluded to pan out. And so you've got potentially very large opportunities across metastatic -- melanoma -- across, I'm sorry, adjuvant melanoma, gastric, bladder, renal, esophageal and potentially HCC. So these are potentially large and very attractive opportunities.

Well, Bristol-Myers is certainly more than just an oncology company, and I want to touch upon a couple of other therapeutic areas, maybe starting with your TYK2 in immunology. Chris, when you think about the opportunity for the TYK2 relative to others or other mechanisms that are out there at least in psoriasis, such as when JAK inhibitors and some of the injectables. Where would you ideally like to place TYK2? What is the -- we know the profile so far looks quite strong both on an efficacy and safety standpoint as well as that convenience. But there's also this incumbency that exists with the injectables. How -- where are you thinking of positioning this asset?

Yes. So moderate to severe psoriasis, which will be the initial launch indication for TYK is a very large area, and it's an area of significant unmet need in large part because of the efficacy of existing agents and the specific profile that you have. So in terms of overall prevalence, this is about a 1.5 million patient opportunity in the moderate to severe population across the U.S. and the largest European and Japanese markets. The challenge in the space has really been the fact that very few patients are ultimately treated with the most efficacious agents. So patients start typically on topicals. And then on the other end of the spectrum, you have biologics and injectables. The biologics and injectables have better efficacy. The problem is that dermatologists have been reluctant to use a lot of those drugs primarily because of the safety profile of them. And you mentioned the JAK inhibitors. That's sort of one illustration of that, with some of the toxicities associated with these products don't play well particularly for dermatologists who tend to be somewhat risk-averse. As a result of that, only about 15% of patients with moderate to severe disease ever get treated with these more efficacious agents. The vast majority are treated with topicals, which have the advantage of being relatively easy to administer, but less efficacious. What we like about the potential profile for TYK from the Phase II data was that we saw biologic-like efficacy, a 75% response rate on the PASI 75 efficacy score with a very manageable safety profile. And we think that profile, particularly remember that Phase II was run against an active comparator in OTEZLA, we think that profile is potentially very attractive and provides a potential opportunity sitting between topicals and biologics where TYK2 can really own that space. Now obviously, that's going to be dependent upon the Phase III data. But based on what we've seen so far, we think there's a real opportunity to bring to this market biologic-like activity in a more safe and convenient oral formulation.

And maybe the last question here, since we're running up against time, but the -- your Factor XI, important to help you with your life cycle management of Eliquis. The stroke prevention Phase II reads out next year. This is an asset that is not well understood -- broadly understood as some of your other assets. Samit, could you remind us of your -- how we think -- we should be thinking about this mechanism relative to what's already out there? What role could this asset play? And what indications are you looking at beyond stroke prevention?

Sure. Thank you for the question. I think when we look at Factor XIa, there are 3 elements that are going to be very, very critical. From a biologic perspective, we know that when in hemophilia C, for example, when there is a decrease in the levels of Factor XIa. And if you follow these patients, there is a decreased propensity to develop coagulation. So we know that inhibiting Factor a does not necessarily lead to increase the bleeding but does decrease the propensity towards coagulation. So biologically, it makes sense that you can go after that. Secondly, from a, again, pathway perspective, targeting the intrinsic pathway versus the common pathway differentiates it from what we are doing with Eliquis with Factor Xa inhibition versus what we can do with Factor XI. Third, with Factor Xa, when we look at some of the studies that have been done in combination with the background therapy of anti-platelet agents, we do see that there is a propensity towards increase in bleeding episodes, whereas the early data, our initial data, especially in the ways we've looked at, we don't see that there is increased propensity. So that's why the study that we're looking at in terms of secondary stroke prevention, we are looking at a combination with a background therapy of Plavix or aspirin. So taking all of these into account, I think what Factor XIa does is provide us an opportunity to develop this drug in indications even beyond what we thus far have with Eliquis looking at single agent as well as the combination with other anticoagulants or anti-platelet agents for multitude of indications. Now to get to those indications, we need to define a dose. We need to define the schedule. We need to define the longevity of treatment required. And to do that, we have 2 studies ongoing in partnership with Janssen, so we are conducting, as BMS, the secondary stroke prevention study. It is more than 2,000 patients study that is currently ongoing. And then Janssen is doing the study in patients with total knee replacement. We will require the data from these trials to be able to define the dose that we will take forward into the next phase of development. And the exact indications where we will be going after, that is still being discussed. And certainly, when the time is right, we will be able to share that with you.

I completely lied. We actually have a few minutes left, so which is good because you have a lot of assets I would love to touch upon. We have about 5, 6 more minutes here. So maybe just on ozanimod, suppose you've got actually a very clean label with respect to no first dose monitoring. I mean, could this -- Chris, how are you thinking about it now relative to Novartis' Mayzent and -- for multiple sclerosis? Could we see a better uptake than what we've seen with Mayzent so far?

Well, thanks for the question. And we are very excited about the opportunity that we have with ZEPOSIA. We feel this really does represent a potential best-in-class S1P agent in multiple sclerosis. I think you've highlighted the fact that the label really did come back very clean. We have efficacy that is on par or better than existing oral therapies on traditional physical endpoints. We're the only product to demonstrate prospectively an improvement in novel and, frankly, increasingly important brain endpoints. And as you highlight, the safety profile is superior to other S1Ps, specifically no first dose. Cardiac monitoring was something that we were very happy with. There's no requirement for broad-based ocular testing and there's also no need for extensive genetic testing. And I think all of these have the advantage of allowing physicians to start patients more immediately on therapy. Incidentally, we think that's a particularly important characteristic in a world that we're going to be going into post COVID. So we actually very much like the opportunity that we have. We think the profile looks very good. As I had mentioned previously, we made the decision to delay this launch because of the COVID dynamics. We plan on launching on June 1. The team is ready to launch. We've hired a very experienced commercial team with considerable experience, both in the MS space but also in the broader neuro space. We've had a medical team on the ground for some amount of time engaging with the MS community. And so we have got -- we think the commercial and medical team is ready to launch, and we look forward to doing so on June 1. Now success in this space is going to require us to be very disciplined in how we approach this launch. We've got to make sure we sell the profile that I just highlighted. And clearly, patient experience and getting a positive first patient experience is going to be really important. But I think, again, that plays to the strength at Bristol-Myers Squibb, which is we spent a lot of time focusing on ensuring good patient access Day 1. That's certainly going to be important, as is making sure that we've got the right patient assistance programs for patients in their initial experience with the product, but again, we feel very good about where we are and very much look forward to launching the product.

And then you're also studying ozanimod in GI in Phase II -- in Phase III right now. The data in Phase II looked good. Maybe Samit, could you remind us about the readouts for the GI trials? And how should we think about your expectations for activity relative to what we've seen with the JAKs? And then I have one final question after that.

Yes. I think, again, we're looking at IBD as a -- from a holistic point of view, not only through the S1P inhibitor as in our S1P-directed therapy, such as in ozanimod, but also looking at it from a TYK2 perspective. So both of those are in development for IBD. Certainly for ozanimod, we are in the Phase III of the trials. The ulcerative colitis data, we should have a readout by the end of this quarter, early next quarter. So we're looking forward to that readout, and then that will dictate where we go from there. The Crohn's disease trial is continuing to enroll. That's going to take a little bit longer. These are not easy trials to enroll, as you can imagine. So we're looking forward to that readout in a couple of years from now as well. For TYK2 program, the Phase II studies, both in UC and CD are ongoing. So that also will be reading out in 2022 time frame.

I was just going to say, in the IBD space, I mean, I think that's very interesting from a commercial standpoint, both UC and Crohn's disease are chronic conditions requiring multiple treatments to manage. And we think there's a real opportunity, both in the pre biologics space for drugs that are safe and convenient but have efficacy that is comparable to biologics. That's especially true in Crohn's disease, which really doesn't have a well-established first-line treatment. And then also in the post biologic space, where, again, you need safe options with different MOAs for patients who have, perhaps, developed immunogenicity to biologics. So pending the data, we think there's real opportunity in IBD for ozanimod.

And for bb2121 ide-cel, on the RTF, could you clarify if the additional documents -- documentation required maybe around questions around the potency release assays with the lentiviral vector used by blue's LentiGlobin? And then also, are you -- how confident are you in your ability to refile by July?

So the answer to both questions is pretty simple, in the sense that what we've said. We're not going to get into the specifics of the questions that have been asked, of course, but they are related to CMC and module 3, where we don't have to conduct new experiments or new data from our preclinical or clinical perspective, but rather be able to provide more detailed information around what summaries we had provided to the agency. And because we don't have to do new clinical studies, new preclinical studies, et cetera, we will be able to compile that, and we look forward to that further dialogue with the agency and be able to file before the end of July as we have promised on the call.

Well, that is very clear. And with that, I really want to thank Chris and Samit for joining us today from Bristol-Myers Squibb. I hope you all have a lovely rest of the day. And thank you for everyone online who has joined us.

Thanks, Navin.

Thank you very much.

Take care. Bye-bye.